This standard is aimed at manufacturers of medical devices who must comply with international, European or national legal regulations as well as corresponding customer requirements. Examples are Canadian, US-American or Japanese requirements as well as the European directives for medical devices and in-vitro diagnostics. With a certificate according to ISO 13485, these companies document that their management system complies with the requirements of the standard.

ISO 13485:2016 may not only be applied by medical device manufacturers, but also by suppliers or external parties providing goods as well as services to medical device manufacturing organizations.

DQS Medizinprodukte GmbH is accredited by the German Accreditation Body (DAkkS) as well as by the Standards Council of Canada (SCC) for ISO 13485:2016.

Szymon Kurdyn
Head of Notified Body

Product Manager ISO 13485